Predictive factors of revision stapes surgery in otosclerosis.

OBJECTIVES: This study aimed to investigate predictive factors for revision surgery in otosclerosis. METHODS: This was a retrospective, multicentre study in four tertiary centres. The primary objective was to investigate factors that were predictive of the need for revision stapes surgery. RESULTS: The 'revision' group included 145 patients, and the 'control' group included 143 patients. This study identified statistically significant predictive factors for the need for revision surgery: younger age, active smoking status, dyslipidaemia and high blood pressure. There was no statistically significant difference between the two groups in terms of surgical technique or stapedotomy technique. CONCLUSION: This study showed that patients who are candidates for primary stapes surgery with younger age, active smoking status, dyslipidaemia and high blood pressure are at higher risk of needing revision surgery. A holistic approach prior to stapes surgery with multidisciplinary assessment is recommended. These results are important for better patient counselling on expected outcomes and risks.

Otosclerosis surgery under local anesthesia with sedation: Assessment of quality of life and stress.

OBJECTIVES: The main study endpoint was tolerance of stapedotomy under local anesthesia with sedation and under general anesthesia using stress and quality of life assessment questionnaires. Secondary endpoints comprised operative time and functional results. MATERIAL AND METHOD: In a consecutive series of stapedotomy patients operated on over a 12-month period, quality of life and perioperative stress were analysed by 3 questionnaires: the Glasgow Benefit Inventory, Cohen's perceived stress scale and the Post-traumatic stress disorder checklist scale. Questionnaire responses and audiometric data were compared between groups treated under local anesthesia with sedation and under general anesthesia. RESULTS: Twenty-two patients were included in the local anesthesia with sedation group and 6 in the general anesthesia group. There was no difference between the groups for quality of life, onset of post-traumatic stress, or perceived pre- and postoperative stress. There was also no difference in operative time. The audiometric data confirmed the reliability of stapedotomy. Stapedotomy under local anesthesia with sedation improved air conduction with≤10dB air-bone gap (ABG), comparable to results under general anesthesia. The rate of ABG≤10dB was 71.4%; no labyrinthisation was observed. CONCLUSION: Under local anesthesia with sedation, stapedotomy was well tolerated without increasing the stress associated with otosclerosis surgery. By correcting hearing loss, the procedure improves quality of life.

Stapes surgery for otosclerosis under local anaesthesia with sedation.

The stapes surgery surgical technique has now been clearly standardized, ensuring a reliable and reproducible procedure with a satisfactory success rate. The possibility of performing this surgery under local anaesthesia with sedation requires very good collaboration between surgeons and anaesthetists. The patient is informed about the various steps of the operation to ensure that he or she is reassured both before and during the procedure. Local anaesthesia with sedation constitutes an alternative in patients afraid of general anaesthesia. Sudden onset of dizziness reported by the patient during the operation after piston placement may be due to an excessively long piston, which may need to be adjusted. We describe the technique used in our centre. In the literature, there is no difference in terms of audiometric performance and dizziness between patients operated under local anaesthesia with sedation or general anaesthesia.

Hearing Outcomes and Complications in Stapes Surgery for Otosclerosis Performed Under General or Local Anesthesia.

OBJECTIVE: Stapes surgery is highly successful in reducing or eliminating the audiometric air-bone gap (ABG) related to otosclerosis, and it can be performed under general anesthesia or local anesthesia with sedation. Literature on the relative outcomes of these 2 modalities is lacking. The purpose of this study was to compare hearing outcomes for these 2 modalities in a large patient population. STUDY DESIGN: Retrospective review. SETTING: Large otology referral center. METHODS: Patients undergoing primary stapes surgery for otosclerosis from 2005 to 2017 were grouped by anesthetic modality and their cases reviewed. Pre- and postoperative ABGs were primary outcomes. RESULTS: A total of 580 patients undergoing stapes surgery were included: 46% received local anesthesia and 54% received general anesthesia. These 2 groups were similar in demographic and disease characteristics. Mean preoperative ABGs were 25.6 and 26.6 dB for patients undergoing local and general anesthesia, respectively (P = .2); mean postoperative ABGs were 9.5 and 9.7 dB (P = .9). There were no significant differences in the rates of complications, the need for revision surgery, or the need to abort surgery intraoperatively between local and general anesthesia. CONCLUSION: Consistent with limited prior data, in this cohort stapes surgery yielded similar hearing outcomes whether performed under general anesthesia or local anesthesia with sedation. While we report the largest sample size to date, this study, like previous work, carries the potential for sampling bias. Prospective study comparing local and general anesthesia for stapes surgery is needed.

Effect of CO2 laser for the management of primary otosclerosis: A protocol for systematic review and meta-analysis.

BACKGROUND: This study will explore the effect and safety of CO2 laser (COL) for the management of patients with primary otosclerosis (PO). METHODS: The following electronic databases will be searched from inception to the present: PUBMED, EMBASE, The Cochrane Library, Web of Science, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, VIP, WANGFANG, and China National Knowledge Infrastructure. No language limitation will be applied. All relevant randomized controlled trials using COL to treat patients with PO will be included. Two researchers will identify studies, collect data and evaluate the risk of bias of each included study independently. Any different views between 2 researchers will be resolved by a third researcher via discussion. Data analysis will be carried out using RevMan 5.3 software. RESULTS: This study will evaluate the effect and safety of COL for the treatment of PO through hearing gain, tinnitus severity, incidence of intraoperative, health-related quality of life, other morbidities, and adverse events. CONCLUSION: This study will provide evidence for the effect and safety of COL in patients with PO. STUDY REGISTRATION NUMBER: INPLASY202040110.

Mid-term evaluation of perioperative i.v. corticosteroid treatment efficacy on overall and audiological outcome following CO2 laser stapedotomy: a retrospective study of 84 cases.

PURPOSE: Our aim was to determine whether perioperatively administered corticosteroid treatment has any beneficial effect on the outcome of stapes surgery, with special regard to the audiological results and early postoperative morbidity. METHODS: 84 CO2 laser stapedotomies performed in our institute between 2013 and 2018 were included in our investigation. All cases underwent preoperative and mid-term postoperative pure-tone audiometric evaluation. Vestibular complications were also evaluated. The cases were subdivided into two groups, 23 patients received perioperative i.v. methylprednisolone treatment ("S") while the other 61 patients ("nS") did not receive any adjuvant pharmacological therapy. The data were analyzed retrospectively using IBM SPSS Statistics. RESULTS: CO2 laser stapedotomy proved to be a successful intervention with a significant improvement in ABG and AC thresholds as well. Long-term BC levels were significantly better compared to preoperative ones in the S group; however, in the nS group, no difference could be shown. Hearing and ABG gain were significantly superior in group S [28.1 dB (SD11.2) vs. 18.1 dB (SD 10.9) and 23.9 dB(SD 9.8) vs. 17.2 dB (SD 9.5), respectively]. CONCLUSION: No significant inner ear damage was detectable in the results of our CO2 laser stapedotomy method; however, the positive effect of corticosteroid treatment could be demonstrated through the postoperative hearing levels. We found no statistical difference in early postoperative morbidity. According to our data, the routine administration of corticosteroids during stapes surgery could be an issue worthy of consideration. The effects of perioperative treatment vs that on the first day after surgery, and topical vs. systemic treatment could be the subject of further investigation in a prospective manner.

Otosclerosis surgery: Assessment of patient comfort.

OBJECTIVES: To evaluate operative comfort and stress in patients undergoing stapedotomy for otosclerosis under local versus general anesthesia. MATERIAL AND METHODS: Consecutive otosclerosis patients managed over a 9-month period responded to 3 validated questionnaires to assess peri- and post-operative comfort: Glasgow Benefit Inventory, Cohen's Perceived Stress Scale and the Posttraumatic Stress Disorder Checklist Scale. These results and audiometric data were compared between local and general anesthesia groups. RESULTS: Twenty-one patients were included in the local anesthesia group and 7 in the general anesthesia group, after exclusion of patients with history of otosclerosis surgery. There was no significant inter-group difference on Glasgow Benefit Inventory (P=0.38) or Posttraumatic Stress Disorder Checklist Scale (P=0.86). Perceived Stress Scale scores were higher in the general anesthesia group (P=0.038). In total, 67% of patients reported no discomfort under local anesthesia, and 86% were ready to undergo the procedure under local anesthesia again. There were no significant differences in postoperative symptoms, or in air-bone gap≤10dB (local anesthesia 81%, general anesthesia 71%; P=0.156). CONCLUSIONS: Local anesthesia in otosclerosis surgery did not increase stress or postoperative symptoms compared to general anesthesia. Audiometric results were not affected by type of anesthesia.

Successful hearing improvement with direct acoustic stimulation in a patient with schizophrenia.

OBJECTIVE: A direct acoustic cochlear implant provides its power directly to the inner ear by vibrating the perilymph via a conventional stapes prosthesis. Our experience with a patient with severe mixed hearing loss due to otosclerosis is described.Case reportThe patient, a 47-year-old male, had a pre-operative speech recognition score of 10 per cent and had been treated for many years for schizophrenia, both of which made him a poor candidate for a direct acoustic stimulation device. Nevertheless, the surgery was performed, which preserved the pre-operative bone conduction level and significantly improved hearing. His speech recognition score rose to 100 per cent. He uses the device all day and his auditory hallucinations have subsided. Improvement of schizophrenia symptoms has enabled the patient to reduce his psychiatric medications intake. CONCLUSION: Hearing restoration was the main reason for the reduction of auditory hallucinations in our patient. Hearing loss is a potentially reversible risk factor for psychosis, but this association is often overlooked.

New chamber stapes prosthesis - A preliminary assessment of the functioning of the prototype.

Piston-stapedotomy is the most common method for hearing restoration in patients with otosclerosis. In this study, we have experimentally examined a prototype of a new chamber stapes prosthesis. The prototype was implanted in a human cadaver temporal bone. The round window vibrations before and after implantation were measured for the acoustic signal (90 dB SPL, 0.8-8 kHz) in the external auditory canal. In comparison with a 0.4-mm piston prosthesis, the chamber prosthesis induced significantly higher vibration of the round window, especially for frequencies above 1.5 kHz. Based on the results, it can be surmised that stapedotomy with a chamber stapes prosthesis could provide better hearing results in comparison with the piston-stapedotomy.

The Effect of Piston Diameter in Stapedotomy for Otosclerosis: A Temporal Bone Model.

HYPOTHESIS: The use of larger-diameter pistons in stapedotomy leads to better hearing outcomes compared with the use of smaller-diameter pistons. There is an interaction between stapes piston diameter and fenestration diameter. BACKGROUND: Otosclerosis can be treated surgically by removing part of the stapes and bypassing the stapes footplate with a prosthesis. Available piston shaft diameters range between 0.3 and 0.8 mm. There has been a tendency toward the use of smaller-diameter pistons, because of a suspected decreased risk of cochlear trauma and subsequent sensorineural hearing loss (SNHL) with smaller pistons. However, mathematical models, temporal bone studies, and clinical studies suggest that the use of larger-diameter pistons is associated with better hearing outcomes. METHODS: Three fresh-frozen, non-pathologic temporal bones were harvested from human cadaveric donors. Acoustic stimuli in the form of pure tones from 250 to 8000 Hz were generated at 110 dB sound pressure level. A total of 16 frequencies in a 1/3-octave series were used. Stapes and round window velocities in response to the acoustic stimuli were measured at multiple equally spaced points covering the stapes footplate and round window using a scanning laser Doppler interferometry system. Eight sets of measurements were performed in each temporal bone: 1) normal condition (mobile stapes), 2) stapes fixation and stapedotomy followed by insertion of 3) a 0.4-mm-diameter piston in a 0.5-mm-diameter fenestration, 4) a 0.4-mm-diameter piston in a 0.7-mm-diameter fenestration, 5) a 0.4-mm-diameter piston in a 0.9-mm-diameter fenestration, 6) a 0.6-mm-diameter piston in a 0.7-mm-diameter fenestration, 7) a 0.6-mm-diameter piston in a 0.9-mm-diameter fenestration, and 8) a 0.8-mm-diameter piston in a 0.9-mm-diameter fenestration. RESULTS: At midrange frequencies, between 500 and 4000 Hz, round window velocities increased by 2 to 3 dB when using a 0.6-mm-diameter piston compared with a 0.4-mm-diameter piston. Using a 0.8-mm-diameter piston led to a further increase in round window velocities by 2 to 4 dB. CONCLUSION: Our results suggest a modest effect of piston diameter on hearing results following stapedotomy.

A comparison of hearing results following stapedotomy under local versus general anesthesia.

Advances in operative technique, instrumentation, and prosthesis design in otosclerosis surgery continue since Shea performed the first successful surgery. This is the first analysis to specifically compare post-operative hearing outcomes following stapedotomy surgery performed under local versus general anesthesia. Hearing outcomes were further stratified by comparing conventional perforator and Er:YAG laser ablation perforation techniques. Pre- and post-operative audiograms were retrospectively analyzed together with the method of anesthesia and the perforation technique for all patients with otosclerosis who underwent stapedotomy between 1998 and 2007. Pre-operative individual standard audiometry frequency thresholds (IFTs), air (AC) and bone conduction pure tone averages (PTA), and air bone gaps (ABG) were compared against post-operative results. Differences between pre- and post-operative PTAs and ABGs were compared between patients who received stapedotomy under local versus general anesthesia, as well as for patients who underwent conventional versus Er:YAG laser ablation perforations. Eighty-six patients were identified of which 24 % (n = 21) received local and 76 % (n = 65) received general anesthesia. Post-operative audiograms were available for 84 and 48 patients, respectively. Significant improvements were seen across all groups for standard 4-frequency AC-PTA and ABG and for IFTs up to 3 kHz. No significant difference was seen for IFTs between 4 and 6 kHz. A significant decline in post-operative hearing thresholds was seen at 8 kHz. Significant improvements in PTA and ABG were seen for all groups. There was a trend toward general compared to local anesthesia post-operative hearing results furthermore in combination with conventional perforation technique then with laser technique.

Local versus general anesthesia in stapes surgery for otosclerosis: a systematic review of the evidence.

OBJECTIVE: To assess hearing results following primary stapes surgery in patients with otosclerosis, comparing local and general anesthesia. DATA SOURCES: PubMed, Embase, the Cochrane Library, CINAHL, and Scopus. REVIEW METHODS: A systematic search was conducted, followed by assessment of directness of evidence and risk of bias. Studies reporting original data on the effect of local anesthesia, compared to general anesthesia, on closure of air-bone gap in patients undergoing stapes surgery for otosclerosis were included. RESULTS: A total of 257 unique studies were retrieved, of which 3 (including 417 procedures) satisfied the eligibility criteria. Assessment showed that all studies carried high risk of bias, and only 1 study provided direct evidence. CONCLUSION: There is no difference in postoperative air-bone gap, worsening of sensorineural hearing loss, and postoperative vertigo between the 2 groups. A statistically significant increased risk of immediate dead ear following stapes surgery performed under general anesthesia was reported in 1 study.

Hyposalivation: the roles of radioactive iodine and stapes surgery.

PURPOSE: The aim of this study is to call attention to the role that radioactive iodine ((131)I) and stapes surgery may play in causing hyposalivation. MATERIALS AND METHODS: The manner in which (131)I and stapes surgery can cause salivary damage was reviewed. A case report is presented to illustrate the involved pathophysiology. RESULTS: The case report clearly shows the significant injury to the parotid glands caused by the (131)I. However, subjective symptoms of oral dryness only developed after injury to the chorda tympani nerve (CTN) during stapes surgery. CONCLUSIONS: The loss of function of both parotid glands after (131)I therapy for thyroid cancer was initially compensated by the secretions of the more radiation-resistant submandibular and sublingual salivary glands (SMSG/SLSG). Damage to the CTN's secretory fibers in one SMSG/SLSG complex led to subjective oral dryness by accentuating an existing objective hyposalivation.

Assessment of a direct acoustic cochlear stimulator.

This study aimed to assess the functional results of a new, active, acoustic-mechanical hearing implant, the Direct Acoustic Cochlear Stimulation Partial Implant (DACS PI), in a preclinical study. The DACS PI is an electromagnetic device fixed to the mastoid by screws and coupled to a standard stapes prosthesis by an artificial incus (AI). The function of the DACS PI-aided reconstruction was assessed by determining: (1) the maximum equivalent sound pressure level (SPL) of the implant, which was obtained from measurements of the volume displacement at the round window in normal and implanted ears, and (2) the quality at the coupling interface between the AI of the DACS and the stapes prosthesis, which was quantified from measurements of relative motions between the AI and the prosthesis. Both measurements were performed with fresh temporal bones using a scanning laser Doppler interferometry system. The expected maximum equivalent SPL with a typical driving voltage of 0.3 V was about 115-125 dB SPL up to 1.5 kHz in reconstruction with the DACS PI, and decreased with a roll-off slope of about 65 dB/decade, reaching 90 dB SPL at 8 kHz. The large roll-off relative to a normal ear was presumed to be a relatively high inductive impedance of the coil of the DACS PI actuator at higher frequencies. Good coupling quality between the AI and the prosthesis was achieved below the resonance (∼1.5 kHz) of the DACS PI for all tested stapes prostheses. Above the resonance, the SMart Piston, which is composed of a shape-memory alloy, had the best coupling quality.

Third-window vibroplasty with an active middle ear implant: assessment of physiologic responses in a model of stapes fixation in Chinchilla lanigera.

HYPOTHESIS: Mechanical stimulation through a cochlear third window into the scala tympani in a chinchilla model with normal and fixed stapes can generate cochlear responses equivalent to acoustic stimuli. BACKGROUND: Cochlear stimulation via the round window (RW) using active middle ear implants (AMEIs) can produce physiologic responses similar to acoustic stimulation including in a model of stapes fixation. However, pathologic conditions, such as advanced otosclerosis, can preclude delivery of sound energy to the cochlea through the oval window and/or the RW. METHODS: Cochlear microphonic (CM) and laser Doppler vibrometer measurements of stapes and RW velocities were performed in 6 ears of 4 chinchillas. Baseline measurements to acoustic sinusoidal stimuli (0.25-8 kHz) were made. Measurements were repeated with an AMEI driving the RW or a third window to the scala tympani before and after stapes fixation. RESULTS: AMEI stimulation of the third window produced CM waveforms with morphologies similar to acoustic stimuli. CM thresholds with RW and third-window stimulation were frequency dependent but ranged from 0.25 to 10 and 0.5 to 40 mV, respectively. Stapes fixation, confirmed by laser Doppler vibrometer measurements, resulted in a significant frequency dependent impairment in CM thresholds up to 13 dB (at <3 kHz) for RW stimulation and a nonsignificant frequency-dependent improvement of up to 10 dB (at >3 kHz) via third-window stimulation. CONCLUSION: AMEI mechanical stimulation through a third window into the scala tympani produces physiologic responses nearly identical to acoustic stimulation including in a model of stapes fixation with decreased efficiency.

Effect of the stapedotomy technique on early post-operative hearing results--Preliminary results.

OBJECTIVE: To compare three stapedotomy modalities used to fenestrate the stapes footplate in patients with primary otosclerosis. MATERIALS: The non-randomized and unblinded one-center study included 48 patients with primary otosclerosis who underwent stapes surgery between May 2008 and April 2009. The patients were divided into three groups (single shot and two-shot CO(2) laser stapedotomy, perforator) depending on the modality used for stapedotomy. Bone conduction (BC) and air conduction (AC) thresholds, air-bone gap (ABG), and the difference between mean pre-operative and 2- to 3-week post-operative BC thresholds were analyzed. RESULTS: The temporary BC deterioration was most pronounced at 6 and 8kHz after 2-shot laser stapedotomy. A significant drop in AC or BC was not found in any of our 48 patients. Age, high-dose cortisone therapy, and 'preoperative hearing' did not influence the post-operative hearing results. CONCLUSION: Even though the number of patients presented here was small and statistical analysis was limited, the study showed a trend toward worse BC thresholds at 6 and 8kHz after a second shot CO(2) application. Whenever possible, treatment should avoid a second laser shot on the already opened inner ear with the laser parameters used for the initial shot.

Active middle ear implant application in case of stapes fixation: a temporal bone study.

HYPOTHESIS: Driving the oval window directly with an active middle ear implant (AMEI) can produce high levels of input to the inner ear. BACKGROUND: Treatment of otosclerosis bypasses the stapes with a piston that penetrates the vestibule. Although this treats the conductive component of hearing loss, it does not treat the sensorineural part, which can be improved using an additional conventional hearing aid. Active middle ear implants have been proposed to be an alternative in treating otosclerosis in cases of mixed hearing losses. METHODS: Seven temporal bones were prepared to expose the stapes and round window (RW). Stapes and RW velocities were measured while driving with an AMEI the stapes head with a bell-shaped tip. The stapes footplate was then fixed with acrylic cement; fixation was confirmed through attenuated RW velocities. A cylinder tip (0.5 mm) was then used to drive the inner ear through a stapedotomy with and without interposition of fascia. RESULTS: Driving the stapes with an AMEI produced mean maximum equivalent ear canal sound pressure levels (SPL) of 138 dB (0.25-8 kHz at 1 V [RMS]). Stapes fixation caused a approximately 25-dB attenuation. Driving with a cylinder tip through the stapedotomy produced 114 dB SPL (24 dB less than normal) and 110 dB SPL (28 dB less than normal) performance with and without fascia, respectively. Performance with fascia was greater than without. CONCLUSION: Driving the oval window with an AMEI in a scenario of stapes fixation was demonstrated to be feasible, with performance comparable to traditional AMEI coupling to the incus or stapes. These possibilities offer new perspectives to treat mixed hearing loss in case of fixed footplate.

Early hearing assessment after "one shot" CO2 laser stapedotomy: is it helpful to predict inner ear damage and the functional outcome?

OBJECTIVE: Auditory testing is not routinely performed within 4 to 6 weeks after stapedotomy because hearing acuity is thought to be transiently depressed. The early postoperative effects of the 1-shot carbon dioxide (CO2) laser have never been reported. The purpose of this study is to present data for auditory thresholds measured within 2 days of laser stapedotomy and at the last follow-up. STUDY DESIGN: The study was prospective and unblinded. SETTING: The study was conducted at the "A. Gemelli" University Hospital. METHODS: From January to December 2008, 58 subjects underwent "1-shot" CO2 laser stapedotomies for otosclerosis. Pure-tonal audiometric test was performed preoperatively 2 days after surgery and at least 1 month after surgery during the follow-up. RESULTS: The closure of air-bone gap began in the early postoperative period and continued to improve through the late postoperative period. Bone-conduction hearing thresholds were stable even in the early postoperative follow-up and remained stable trough all the course of the study. CONCLUSION: Our data, supported by the literature, suggest that 1-shot CO2 laser stapedotomy is an effective and safe procedure for the treatment of otosclerosis.